Prosthetic valve with atrial arms

ABSTRACT

A valve frame is shaped to define a plurality of atrial arms, and a tubular portion that defines a lumen along a longitudinal axis of the valve frame. Prosthetic leaflets within the lumen are coupled to the frame. An outer frame defines a ring and a plurality of ventricular legs coupled to the ring. The ring circumscribes the tubular portion, and is defined by a pattern of alternating peaks and troughs. The tubular portion defines a row of upstream cells, and a row of downstream cells that is tessellated with the row of upstream cells. Each of the atrial arms is attached to, and extends from, a respective connection site at which adjacent upstream cells are connected to each other. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.15/682,789 to Hariton et al., filed Aug. 22, 2017, and entitled“Prosthetic heart valve with compressible frames,” which published as US2017/0367823 (now U.S. Pat. No. 10,449,047), and which is a Continuationof U.S. patent application Ser. No. 15/541,783 to Hariton et al., filedJul. 6, 2017, and entitled “Prosthetic valve with axially-slidingframes,” which published as US 2018/0014930 (now U.S. Pat. No.9,974,651) which is the US National Phase of PCT applicationIL2016/050125 to Hariton et al., filed Feb. 3, 2016, and entitled“Prosthetic valve with axially-sliding frames,” which published as WO2016/125160, and which claims priority from U.S. Provisional PatentApplication 62/112,343 to Hariton et al., filed Feb. 5, 2015, andentitled “Prosthetic valve with axially-sliding frames,” which isincorporated herein by reference.

FIELD OF THE INVENTION

Some applications of the present invention relate in general to valvereplacement. More specifically, some applications of the presentinvention relate to prosthetic valves for replacement of a cardiacvalve.

BACKGROUND

Ischemic heart disease causes regurgitation of a heart valve by thecombination of ischemic dysfunction of the papillary muscles, and thedilatation of the ventricle that is present in ischemic heart disease,with the subsequent displacement of the papillary muscles and thedilatation of the valve annulus.

Dilation of the annulus of the valve prevents the valve leaflets fromfully coapting when the valve is closed. Regurgitation of blood from theventricle into the atrium results in increased total stroke volume anddecreased cardiac output, and ultimate weakening of the ventriclesecondary to a volume overload and a pressure overload of the atrium.

SUMMARY OF THE INVENTION

For some applications, an implant is provided having a tubular portion,an upstream support portion and one or more flanges. The implant ispercutaneously deliverable to a native heart valve in a compressedstate, and is expandable at the native valve. The implant and itsdelivery system facilitate causing the upstream support portion and theflanges to protrude radially outward from the tubular portion withoutexpanding the tubular portion. Expansion of the tubular portion bringsthe upstream support portion and the flanges closer together, forsecuring the implant at the native valve by sandwiching tissue of thenative valve between the upstream support portion and the flanges.

There is therefore provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen;

an outer frame:

-   -   including a ring defined by a pattern of alternating peaks and        troughs, the peaks being longitudinally closer to the upstream        end than to the downstream end, and the troughs being        longitudinally closer to the downstream end than to the upstream        end, and the pattern of the ring having an amplitude        longitudinally between the peaks and the troughs,    -   including a plurality of legs, each of the legs coupled to the        ring at a respective trough, and    -   shaped to define a plurality of outer-frame coupling elements,        each of the outer-frame coupling elements (i) coupled to the        ring at a respective peak, and (ii) fixed with respect to

a respective valve-frame coupling element,

and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

the fixation of the outer-frame coupling elements to the valve-framecoupling elements is such that compression of the tubular portion fromthe expanded state toward the compressed state such that the valve-framecoupling elements pull the outer-frame coupling elements radiallyinward: (i) reduces a circumferential distance between each of theouter-frame coupling elements and its adjacent outer-frame couplingelements, and (ii) increases the amplitude of the pattern of the ring.

In an application, the ring circumscribes the tubular portion.

In an application, the valve-frame coupling elements are disposedcircumferentially around the longitudinal axis between the upstream endand the downstream end but not at the upstream end nor at the downstreamend.

In an application, the upstream support portion includes one or morefabric pockets disposed circumferentially, each pocket of the one ormore pockets having an opening that faces a downstream direction.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

In an application, the apparatus further includes an upstream supportportion that includes a plurality of arms that extend radially from thetubular portion, and:

the upstream support portion has (i) a constrained-arm state, and (ii) areleased-arm state in which the arms extend radially outward from thetubular portion,

each leg has a tissue-engaging flange that has (i) a constrained-flangestate, and (ii) a released-flange state in which the flange extendsradially outward from the tubular portion, and

the apparatus has an intermediate state in which (i) the tubular portionis in its compressed state, (ii) the upstream support portion is in itsreleased-arm state, and (iii) the legs are in their released-flangestate.

In an application:

the apparatus includes an implant that includes the valve frame, theleaflets, and the outer frame, and

the apparatus further includes a tool:

-   -   including a delivery capsule dimensioned (i) to house and retain        the implant in a compressed state of the implant in which (a)        the tubular portion is in its compressed state, (b) the upstream        support portion is in its constrained-arm state, and (c) the        legs are in their constrained-flange state, and (ii) to be        advanced percutaneously to the heart of the subject while the        implant is housed and in its compressed state, and    -   operable from outside the subject to:        -   transition the implant from its compressed state into the            intermediate state while retaining the tubular portion in            its compressed state, and        -   subsequently, expand the tubular portion toward its expanded            state.

In an application, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by (i) releasing the legs into their released-flange state, whileretaining the tubular portion in its compressed state, and (ii)subsequently, releasing the upstream support portion into itsreleased-arm state, while retaining the tubular portion in itscompressed state.

In an application, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by (i) releasing the upstream support portion into itsreleased-arm state, while retaining the tubular portion in itscompressed state, and (ii) subsequently, releasing the legs into theirreleased-flange state, while retaining the tubular portion in itscompressed state.

In an application, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from itscompressed state toward its expanded state moves the flangeslongitudinally away from the valve-frame coupling elements.

In an application, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from itscompressed state toward its expanded state reduces the amplitude of thepattern of the ring and passes the flanges between the arms.

In an application, the upstream support portion further includes acovering that covers the arms to form an annular shape in thereleased-arm state, and, when the apparatus is in its intermediatestate, expansion of the tubular portion from its compressed state towardits expanded state presses the flanges onto the covering.

In an application, in the compressed state of the tubular portion, adownstream end of each leg is longitudinally closer than the valve-framecoupling elements to the downstream end, and the flange of each leg isdisposed longitudinally closer than the valve-frame coupling elements tothe upstream end.

In an application, in the expanded state of the tubular portion, thedownstream end of each leg is longitudinally closer than the valve-framecoupling elements to the downstream end, and the flange of each leg isdisposed longitudinally closer than the valve-frame coupling elements tothe upstream end.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including an implant that includes:

a valve frame that includes a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion having an upstream end, a downstream end, alongitudinal length therebetween, and a diameter transverse to thelongitudinal axis;

a valve member, coupled to the tubular portion, disposed within thelumen, and arranged to provide unidirectional upstream-to-downstreamflow of blood through the lumen;

an upstream support portion, coupled to the tubular portion; and

an outer frame, coupled to the tubular portion, and including atissue-engaging flange, and:

the implant has a first state and a second state,

in both the first state and the second state, (i) the upstream supportportion extends radially outward from the tubular portion, and (ii) thetissue-engaging flange extends radially outward from the tubularportion, and

the tubular portion, the upstream support portion, and the outer frameare arranged such that transitioning of the implant from the first statetoward the second state:

-   -   increases the diameter of the tubular portion by a        diameter-increase amount,    -   decreases the length of the tubular portion by a length-decrease        amount, and    -   moves the flange a longitudinal distance toward or        toward-and-beyond the upstream support portion, the distance        being greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion,and the outer frame are arranged such that the longitudinal distance ismore than 20 percent greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion,and the outer frame are arranged such that the longitudinal distance ismore than 30 percent greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion,and the outer frame are arranged such that the longitudinal distance ismore than 40 percent greater than the length-decrease amount.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen;

an outer frame, including:

-   -   a ring defined by a pattern of alternating peaks and troughs:        -   the peaks being longitudinally closer than the troughs to            the upstream end,        -   the peaks being fixed to respective sites of the tubular            portion at respective coupling points disposed            circumferentially around the longitudinal axis, and        -   the pattern of the ring having an amplitude longitudinally            between the peaks and the troughs; and    -   a plurality of legs, each of the legs coupled to the ring at a        respective trough,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

the fixation of the peaks to the respective sites of the tubular portionis such that compression of the tubular portion from the expanded statetoward the compressed state such that the respective sites of thetubular portion pull the peaks radially inward via radially-inwardtension on the coupling points: (i) reduces a circumferential distancebetween each of the coupling points and its adjacent coupling points,and (ii) increases the amplitude of the pattern of the ring.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the valve frame defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen;

an outer frame:

-   -   including a ring defined by a pattern of alternating peaks and        troughs, the peaks being longitudinally closer to the upstream        end than to the downstream end, and the troughs being        longitudinally closer to the downstream end than to the upstream        end, and the pattern of the ring having an amplitude        longitudinally between the peaks and the troughs,    -   including a plurality of legs, each of the legs coupled to the        ring at a respective trough, and    -   shaped to define a plurality of outer-frame coupling elements,        each of the outer-frame coupling elements (i) coupled to the        ring at a respective peak, and (ii) fixed with respect to a        respective valve-frame coupling element,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

the fixation of the outer-frame coupling elements with respect to thevalve-frame coupling elements is such that compression of the tubularportion from the expanded state toward the compressed state (i) pullsthe outer-frame coupling elements radially inward via radially-inwardpulling of the valve-frame coupling elements on the outer-frame couplingelements, (ii) reduces a circumferential distance between each of theouter-frame coupling elements and its adjacent outer-frame couplingelements, and (iii) increases the amplitude of the pattern of the ring,without increasing a radial gap between the valve frame and the ring bymore than 1.5 mm

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen;

an outer frame, including:

-   -   a ring defined by a pattern of alternating peaks and troughs:        -   the peaks being longitudinally closer than the troughs to            the upstream end,        -   the peaks being fixed to respective sites of the tubular            portion at respective coupling points disposed            circumferentially around the longitudinal axis, and        -   the pattern of the ring having an amplitude longitudinally            between the peaks and the troughs; and    -   a plurality of legs, each of the legs coupled to the ring at a        respective trough,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

the fixation of the peaks to the respective sites of the tubular portionis such that compression of the tubular portion from the expanded statetoward the compressed state (i) pulls the peaks radially inward viaradially-inward pulling of the respective sites of the tubular portionon the peaks, (ii) reduces a circumferential distance between each ofthe coupling points and its adjacent coupling points, and (iii)increases the amplitude of the pattern of the ring, without increasing aradial gap between the valve frame and the ring by more than 1.5 mm

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve disposedbetween an atrium and a ventricle of a heart of a subject, the apparatusincluding:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion having an upstream end, a downstream end, anddefining a plurality of valve-frame coupling elements disposedcircumferentially around the longitudinal axis between the upstream endand the downstream end but not at the upstream end nor at the downstreamend;

a plurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood through the lumen;

an outer frame:

-   -   including a ring defined by a pattern of alternating peaks and        troughs, the peaks being longitudinally closer to the upstream        end than to the downstream end, and the troughs being        longitudinally closer to the downstream end than to the upstream        end,    -   including a plurality of legs, each of the legs coupled to the        ring at a respective trough, and    -   shaped to define a plurality of outer-frame coupling elements,        each of the outer-frame coupling elements (i) coupled to the        ring at a respective peak, and (ii) fixed with respect to a        respective valve-frame coupling element at a respective coupling        point,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

expansion of the tubular portion from the compressed state toward theexpanded state (i) increases a circumferential distance between each ofthe outer-frame coupling elements and its adjacent outer-frame couplingelements, and (ii) moves the plurality of legs in a longitudinallyupstream direction with respect to the tubular portion.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve disposedbetween an atrium and a ventricle of a heart of a subject, the apparatusincluding:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion having an upstream end and a downstream end;

a plurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood through the lumen;

an outer frame, including:

-   -   a ring defined by a pattern of alternating peaks and troughs:        -   the peaks being longitudinally closer than the troughs to            the upstream end,        -   the peaks being fixed to respective sites of the tubular            portion at respective coupling points disposed            circumferentially around the longitudinal axis between the            upstream end and the downstream end but not at the upstream            end nor the downstream end; and        -   a plurality of legs, each of the legs coupled to the ring at            a respective trough,            and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

expansion of the tubular portion from the compressed state toward theexpanded state (i) increases a circumferential distance between each ofthe coupling points and its adjacent coupling points, and (ii) moves theplurality of legs in a longitudinally upstream direction with respect tothe tubular portion.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and acentral longitudinal axis therebetween, and including:

-   -   a valve frame, including:        -   a tubular portion having an upstream end and a downstream            end, and shaped to define a lumen therebetween, and        -   an upstream support portion, extending from the upstream end            of the tubular portion; and    -   at least one leg, coupled to the valve frame at a coupling        point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitateone-way liquid flow through the lumen from the upstream end of thetubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart, in whichthe tubular portion has a compressed diameter,

is biased to assume an expanded state in which the tubular portion hasan expanded diameter that is greater than the compressed diameter, and

is configured such that increasing the diameter of the tubular portiontoward the expanded diameter causes longitudinal movement:

-   -   of the upstream support portion toward the coupling point, and    -   of the tissue-engaging flange away from the coupling point.

In an application:

the apparatus includes an implant that includes the frame assembly andthe valve member, and

the apparatus further includes a tool:

-   -   including a delivery capsule dimensioned (i) to house and retain        the implant in the compressed state, and (ii) to be advanced        percutaneously to the heart of the subject while the implant is        housed and in the compressed state, and    -   operable from outside the subject to facilitate an increase of        the diameter of the tubular portion from the compressed diameter        toward the expanded diameter such that the increase of the        diameter actuates longitudinal movement:        -   of the upstream support portion toward the coupling point,            and        -   of the tissue-engaging flange away from the coupling point.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state causes longitudinal movement of the upstreamend of the tubular portion toward the coupling point.

In an application, the coupling point is disposed closer to thedownstream end of the frame assembly than are either the tissue-engagingflange or the upstream support portion.

In an application, in the expanded state of the frame assembly, the legextends away from the central longitudinal axis.

In an application:

the expanded state of the frame assembly is a fully-expanded state ofthe frame assembly,

the leg is expandable into an expanded state of the leg, independentlyof increasing the diameter of the tubular portion, and

in the expanded state of the leg, the leg extends away from the centrallongitudinal axis.

In an application:

in the expanded state of the frame assembly, the leg extends away fromthe central longitudinal axis, and

in the compressed state of the frame assembly, the leg is generallyparallel with the central longitudinal axis.

In an application, the frame assembly is configured such that thelongitudinal movement of the tissue-engaging flange away from thecoupling point is a translational movement of the tissue-engaging flangethat does not include rotation of the tissue-engaging flange.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state causes 1-20 mm of longitudinal movement of thetissue-engaging flange away from the coupling point.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state causes 1-20 mm of longitudinal movement of theupstream support portion toward the coupling point.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state reduces a distance between the upstreamsupport portion and the tissue-engaging flange by 5-30 mm

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state moves the tissue-engaging flangelongitudinally past the upstream support portion.

In an application:

the tubular portion is defined by a plurality of cells of the valveframe, and

increasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state:

-   -   includes (i) increasing a width, orthogonal to the longitudinal        axis of the frame assembly, of each cell, and (ii) reducing a        height, parallel with the longitudinal axis of the frame        assembly, of each cell, and    -   causes longitudinal movement of the upstream support portion        toward the coupling point by reducing a height, parallel with        the longitudinal axis of the frame assembly, of the tubular        portion, by reducing the height of each cell.

In an application, the leg is disposed on an outside of the tubularportion.

In an application:

the at least one leg includes a plurality of legs,

the coupling point includes a plurality of coupling points, and

the frame assembly includes a leg frame that circumscribes the tubularportion, includes the plurality of legs, and is coupled to the valveframe at the plurality of coupling points, such that the plurality oflegs is distributed circumferentially around the tubular portion.

In an application, the plurality of coupling points is disposedcircumferentially around the frame assembly on a transverse plane thatis orthogonal to the longitudinal axis of the frame assembly.

In an application, the plurality of legs is coupled to the valve framevia a plurality of struts, each strut:

having a first end that is coupled to a leg of the plurality of legs,and a second end that is coupled to a coupling point of the plurality ofcoupling points,

in the compressed state of the frame assembly, being disposed at a firstangle in which the first end is disposed closer to the downstream end ofthe frame assembly than is the second end, and

being deflectable with respect to the coupling point of the plurality ofcoupling points, such that increasing the diameter of the tubularportion by expanding the frame assembly toward the expanded state causesthe strut to deflect to a second angle in which the first end isdisposed further from the downstream end of the frame assembly than isthe first end in the compressed state of the frame assembly.

In an application, the leg frame is structured such that each leg of theplurality of legs is coupled to two struts of the plurality of struts,and two struts of the plurality of struts are coupled to each couplingpoint of the plurality of coupling points.

In an application, the leg is coupled to the valve frame via a strut,the strut:

having a first end that is coupled to the leg, and a second end that iscoupled to the coupling point,

in the compressed state of the frame assembly, being disposed at a firstangle in which the first end is disposed closer to the downstream end ofthe frame assembly than is the second end, and

being deflectable with respect to the coupling point, such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes the strut to deflect to asecond angle in which the first end is disposed further from thedownstream end of the frame assembly than is the first end in thecompressed state of the frame assembly.

In an application, the at least one leg includes at least a first legand a second leg.

In an application, the first leg and the second leg are both coupled tothe valve frame at the coupling point.

In an application, the first leg is coupled to the coupling point via arespective first strut, and the second leg is coupled to the couplingpoint via a respective second strut.

In an application, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly:

the coupling point is disposed, circumferentially with respect to thetubular portion, between the first strut and the second strut,

the first strut is disposed, circumferentially with respect to thetubular portion, between the coupling point and the first leg, and

the second strut is disposed, circumferentially with respect to thetubular portion, between the coupling point and the second leg.

In an application, the coupling point includes at least a first couplingpoint and a second coupling point.

In an application, the leg is coupled to the valve frame at the firstcoupling point and at the second coupling point.

In an application, the leg is coupled to the first coupling point via arespective first strut, and to the second coupling point via arespective second strut.

In an application, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly:

the leg is disposed, circumferentially with respect to the tubularportion, between the first strut and the second strut,

the first strut is disposed, circumferentially with respect to thetubular portion, between the leg and the first coupling point, and

the second strut is disposed, circumferentially with respect to thetubular portion, between the leg and the second coupling point.

In an application, in the expanded state of the frame assembly, theupstream support portion extends radially outward from the tubularportion.

In an application:

the expanded state of the frame assembly is a fully-expanded state ofthe frame assembly,

the upstream support portion is expandable into an expanded state of theupstream support portion, independently of increasing the diameter ofthe tubular portion, and

in the expanded state of the upstream support portion, the upstreamsupport portion extends radially outward from the tubular portion.

In an application, in the compressed state of the frame assembly, theupstream support portion is generally tubular, collinear with thetubular portion, and disposed around the central longitudinal axis.

In an application, in the expanded state of the frame assembly, an innerregion of the upstream support portion extends radially outward from thetubular portion at a first angle with respect to the tubular portion,and an outer region of the upstream support portion extends, from theinner region of the upstream support portion, further radially outwardfrom the tubular portion at a second angle with respect to the tubularportion, the second angle being smaller than the first angle.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and acentral longitudinal axis therebetween, and including:

-   -   a valve frame, including:        -   a tubular portion having an upstream end and a downstream            end, and shaped to define a lumen therebetween, and        -   an upstream support portion, extending from the upstream end            of the tubular portion; and    -   at least one leg, coupled to the valve frame at a coupling        point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitateone-way liquid flow through the lumen from the upstream end of thetubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart, in whichthe tubular portion has a compressed diameter,

is biased to assume an expanded state in which the tubular portion hasan expanded diameter that is greater than the compressed diameter, and

is configured such that reducing the diameter of the tubular portiontoward the compressed diameter causes longitudinal movement:

-   -   of the upstream support portion away from the coupling point,        and    -   of the tissue-engaging flange toward the coupling point.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and acentral longitudinal axis therebetween, including:

-   -   a valve frame, including:        -   a tubular portion having an upstream end and a downstream            end, and shaped to define a lumen therebetween, and        -   an upstream support portion, extending from the upstream end            of the tubular portion; and    -   at least one leg, coupled to the valve frame at a coupling        point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitateone-way liquid flow through the lumen from the upstream end of thetubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart,

is intracorporeally expandable into an expanded state in which adiameter of the tubular portion is greater than in the compressed state,and

is configured such that increasing the diameter of the tubular portionby expanding the frame assembly toward the expanded state causeslongitudinal movement of the tissue-engaging flange away from thecoupling point.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and acentral longitudinal axis therebetween, and including:

-   -   an inner frame including an inner-frame tubular portion that        circumscribes the central longitudinal axis, has an upstream end        and a downstream end, and defines a channel therebetween, the        inner frame defining a plurality of inner-frame couplings        disposed circumferentially at a longitudinal location of the        inner frame,    -   an outer frame including an outer-frame tubular portion that        coaxially circumscribes at least a portion of the inner-frame        tubular portion, the outer frame defining a plurality of        outer-frame couplings disposed circumferentially at a        longitudinal location of the outer frame, and    -   a plurality of connectors, each connector connecting a        respective inner-frame coupling to a respective outer-frame        coupling;

a liner, disposed over at least part of the inner-frame tubular portion;and

a plurality of prosthetic leaflets, coupled to the inner-frame tubularportion and disposed within the channel,

and:

the frame assembly: (i) is compressible by a radially-compressive forceinto a compressed state in which the inner frame is in a compressedstate thereof and the outer frame is in a compressed state thereof, (ii)is configured, upon removal of the radially-compressive force, toautomatically expand into an expanded state thereof in which the innerframe is in an expanded state thereof and the outer frame is in anexpanded state thereof,

in the expanded state of the frame assembly, the prosthetic leaflets areconfigured to facilitate one-way fluid flow, in a downstream direction,through the channel, and

the connection of the inner-frame couplings to the respectiveouter-frame couplings is such that expansion of the frame assembly fromthe compressed state to the expanded state causes the inner-frametubular portion to slide longitudinally in a downstream direction withrespect to the outer-frame tubular portion.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve disposedbetween an atrium and a ventricle of a heart of a subject, the apparatusincluding:

a tubular portion, having an upstream portion that includes an upstreamend, and a downstream portion that includes a downstream end, and shapedto define a lumen between the upstream portion and the downstreamportion;

a plurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood from the upstreamportion to the downstream portion;

an annular upstream support portion:

-   -   having an inner portion that extends radially outward from the        upstream portion, and    -   including one or more fabric pockets disposed circumferentially        around the inner portion, each pocket of the one or more pockets        having an opening that faces a downstream direction.

In an application:

the upstream support portion includes (i) a plurality of arms thatextend radially outward from the tubular portion, and (ii) a covering,disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of theupstream support portion, and (ii) a radially-outer part at the outerportion of the upstream support portion,

at the inner portion of the upstream support portion, the covering isclosely-fitted between the radially-inner parts of the arms, and

at the outer portion of the upstream support portion, the pockets areformed by the covering being loosely-fitted between the radially-outerparts of the arms.

In an application:

the upstream support portion includes (i) a plurality of arms thatextend radially outward from the tubular portion, and (ii) a covering,disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of theupstream support portion, and (ii) a radially-outer part at the outerportion of the upstream support portion, the radially-outer part beingmore flexible than the radially-inner part.

In an application:

the upstream support portion includes (i) a plurality of arms thatextend radially outward from the tubular portion, and (ii) a covering,disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of theupstream support portion, and (ii) a radially-outer part at the outerportion of the upstream support portion,

at the outer portion of the upstream support portion, the pockets areformed by each arm curving to form a hook shape.

In an application, each pocket is shaped and arranged to billow inresponse to perivalvular flow of blood in an upstream direction.

In an application, the apparatus is configured to be transluminallydelivered to the heart, and implanted at the native valve by expansionof the apparatus, such that the upstream support portion is disposed inthe atrium and the tubular portion extends from the upstream supportportion into the ventricle, and each pocket is shaped and arranged suchthat perivalvular flow of blood in an upstream direction presses thepocket against tissue of the atrium.

There is further provided, in accordance with an application of thepresent invention, apparatus including:

a plurality of prosthetic valve leaflets; and

a frame assembly, including:

-   -   a tubular portion defined by a repeating pattern of cells, the        tubular portion extending circumferentially around a        longitudinal axis so as to define a longitudinal lumen, the        prosthetic valve leaflets coupled to the inner frame and        disposed within the lumen;    -   an outer frame, including a plurality of legs, distributed        circumferentially around the tubular portion, each leg having a        tissue-engaging flange;    -   an upstream support portion that includes a plurality of arms        that extend radially outward from the tubular portion; and    -   a plurality of appendages, each having a first end that defines        a coupling element via which the tubular portion is coupled to        the outer frame, and a second end;        and the frame assembly defines a plurality of hubs, distributed        circumferentially around the longitudinal axis on a plane that        is transverse to the longitudinal axis, each hub defined by        convergence and connection of, (i) two adjacent cells of the        tubular portion, (ii) an arm of the plurality of arms, and (iii)        an appendage of the plurality of appendages.

In an application, each hub has six radiating spokes, two of the sixspokes being part of a first cell of the two adjacent cells, two of thesix spokes being part of a second cell of the two adjacent cells, one ofthe six spokes being the arm, and one of the six spokes being the secondend of the appendage.

In an application, the appendages are in-plane with the tubular portion.

In an application, the appendages are in-plane with the outer frame.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including:

percutaneously advancing to heart, an implant:

-   -   including a valve frame, a valve member disposed within a lumen        defined by the valve frame, and at least one leg, coupled to the        valve frame at a coupling point, and    -   having an upstream end, a downstream end, and a central        longitudinal axis therebetween;

positioning the implant within the heart such that a tissue-engagingflange of the leg is disposed downstream of the valve, and thereaftercausing the flange to protrude radially outward from the axis;

subsequently, while an upstream support portion of the valve frame isdisposed upstream of the valve, causing the upstream support portion toprotrude radially outward from the axis, such that tissue of the valveis disposed between the upstream support portion and the flange; and

subsequently, sandwiching the tissue between the upstream supportportion and the flange by reducing a distance between the upstreamsupport portion and the flange by causing longitudinal movement (i) ofthe upstream support portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point.

In an application, causing the longitudinal movement (i) of the upstreamsupport portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point, includes causingthe longitudinal movement by increasing a diameter of the lumen.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including:

percutaneously advancing to heart, an implant:

-   -   including a valve frame, a valve member disposed within a lumen        defined by the valve frame, and at least one leg, coupled to the        valve frame at a coupling point, and    -   having an upstream end, a downstream end, and a central        longitudinal axis therebetween;

positioning the implant within the heart such that an upstream supportportion of the valve frame is disposed upstream of the valve, andthereafter causing the upstream support portion to protrude radiallyoutward from the axis;

subsequently, while a tissue-engaging flange of the leg is disposeddownstream of the valve, causing the tissue-engaging flange to protruderadially outward from the axis, such that tissue of the valve isdisposed between the upstream support portion and the flange; and

subsequently, sandwiching the tissue between the upstream supportportion and the flange by reducing a distance between the upstreamsupport portion and the flange by causing longitudinal movement (i) ofthe upstream support portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point.

In an application, causing the longitudinal movement (i) of the upstreamsupport portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point, includes causingthe longitudinal movement by increasing a diameter of the lumen.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including:

percutaneously advancing an implant to the heart, the implant:

-   -   having an upstream end, a downstream end, and a central        longitudinal axis therebetween, and    -   including a tubular portion, an upstream support portion, and a        plurality of tissue-engaging flanges;

positioning the implant within the heart such that the upstream supportportion is disposed upstream of the valve,

positioning the implant within the heart such that the tissue-engagingflanges are disposed downstream of the valve,

without increasing a diameter of the tubular portion:

-   -   causing the upstream support portion to extend radially outward        from the axis so as to have a first support-portion span, and    -   causing the flanges to extend radially outward from the axis so        as to have a first flange span; and

subsequently, causing the upstream support portion and the flanges movetoward each other by at least 5 mm by increasing a diameter of thetubular portion such that:

-   -   the upstream support portion extends radially outward so as to        have a second support-portion span, the first support-portion        span being at least 40 percent as great as the second        support-portion span, and    -   the flanges extend radially outward so as to have a second        flange span, the first flange span being at least 30 percent as        great as the second flange span.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including:

percutaneously advancing an implant to the heart, the implant:

-   -   having an upstream end, a downstream end, and a central        longitudinal axis therebetween, and    -   including a tubular portion, an upstream support portion, and a        plurality of tissue-engaging flanges;

positioning the implant within the heart such that the upstream supportportion is disposed upstream of the valve,

positioning the implant within the heart such that the tissue-engagingflanges are disposed downstream of the valve,

without increasing a diameter of the tubular portion:

-   -   causing the upstream support portion to extend radially outward        from the axis, and    -   causing the flanges to extend radially outward from the axis so        as to have a first flange span; and

subsequently, by increasing a diameter of the tubular portion:

-   -   causing the upstream support portion and the flanges move toward        each other by at least 5 mm,    -   causing the upstream support portion to move further radially        outward from the axis, and    -   causing each flange of the plurality of flanges to translate        radially outward so as to have a second flange span that is        greater than the first flange span.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B and 2A-E are schematic illustrations of an implant for usewith a native valve of a heart of a subject, in accordance with someapplications of the invention;

FIGS. 3A-C are schematic illustrations that show structural changes in aframe assembly during transitioning of the assembly between itscompressed and expanded states, in accordance with some applications ofthe invention;

FIGS. 4A-F are schematic illustrations of implantation of the implant atthe native valve, in accordance with some applications of the invention;

FIG. 5 is a schematic illustration of a step in the implantation of theimplant, in accordance with some applications of the invention;

FIG. 6 is a schematic illustration of the implant, in accordance withsome applications of the invention;

FIGS. 7A-B and 8A-B are schematic illustrations of frame assemblies ofrespective implants, in accordance with some applications of theinvention; and

FIGS. 9A-C are schematic illustrations of an implant comprising a frameassembly, in accordance with some applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-B and 2A-E, which are schematicillustrations of an implant 20 for use with a native valve of a heart ofa subject, in accordance with some applications of the invention.Implant 20 comprises a frame assembly 22 that has an upstream end 24, adownstream end 26, and a central longitudinal axis ax1 therebetween.Frame assembly 22 comprises a valve frame 30 that comprises a tubularportion 32 that has an upstream end 34 and a downstream end 36, and isshaped to define a lumen 38 through the tubular portion from theupstream end to the downstream end. Tubular portion 32 circumscribesaxis ax1, and thereby defines lumen 38 along the axis. Valve frame 30further comprises an upstream support portion 40, extending fromupstream end 34 of tubular portion 32. Frame assembly 22 furthercomprises at least one leg 50, coupled to valve frame 30 at (e.g., via)a coupling point 52, and having a tissue-engaging flange 54.

Typically, and as described hereinbelow, leg 50 is part of an outerframe (or “leg frame”) 60, and frames 30 and 60 define respectivecoupling elements 31 and 61, which are fixed with respect to each otherat coupling points 52. Typically, frames 30 and 60 are coupled to eachother only at coupling points 52 (e.g., only via the fixation ofcoupling elements 31 and 61 with respect to each other).

Implant 20 further comprises a valve member 58 (e.g., one or moreprosthetic leaflets) disposed within lumen 38, and configured tofacilitate one-way liquid flow through the lumen from upstream end 34 todownstream end 36 (e.g., thereby defining the orientation of theupstream and downstream ends of tubular portion 32). FIG. 1A showsimplant 20 in a fully-expanded state, in which frame assembly 22 is in afully-expanded state. FIG. 1B shows an exploded view of frame assembly22 in its fully-expanded state. FIGS. 2A-E show respective states ofimplant 20, which will be discussed in more detail hereinbelow withrespect to the implantation of the implant and the anatomy in which theimplant is implanted. FIG. 2A shows implant 20 in a compressed state (inwhich frame assembly 22 is in a compressed state), for percutaneousdelivery of the implant to the heart of the subject. Typically, in thecompressed state, leg 50 (including flange 54 thereof) is in aconstrained-flange state in which the flange is generally parallel withaxis ax1. Further typically, in the compressed state, upstream supportportion 40 is generally tubular, collinear with tubular portion 32(e.g., extending collinearly from the tubular portion), and disposedaround axis ax1.

FIG. 2B shows a state of implant 20 in which tissue-engaging flange 54of each leg 50 extends radially away from axis ax1 (e.g., radially awayfrom tubular portion 32). FIG. 2C shows a state of implant 20 in whichupstream-support portion 40 extends radially away from axis ax1 (andthereby radially away from tubular portion 32). FIG. 2D shows a state ofimplant 20 in which both flange 54 and portion 40 extend away from axisax1. In the fully-expanded state (FIGS. 1A-B) both upstream supportportion 40 and flange 54 extend radially away from axis ax1. Typically,frame assembly 22 is biased (e.g., shape-set) to assume itsfully-expanded state, which is shown in FIG. 2E. Transitioning ofimplant 20 between the respective states is typically controlled bydelivery apparatus, such as by constraining the implant in a compressedstate within a delivery tube and/or against a control rod, andselectively releasing portions of the implant to allow them to expand.

In the compressed state of frame assembly 22, tubular portion 32 has adiameter d1, and in the expanded state, the tubular portion has adiameter d2 that is greater that diameter d1. For some applications,diameter d1 is 4-15 mm, (e.g., 5-11 mm) and diameter d2 is 20-50 mm,(e.g., 23-33 mm). Frame assembly 22 is configured such that increasingthe diameter of tubular portion 32 (e.g., from d1 to d2) causeslongitudinal movement of flange 54 away from coupling point 52. In thesame way, reducing the diameter of tubular portion 32 (e.g., from d2 tod1) causes longitudinal movement of flange 54 toward coupling point 52.It is to be noted that the term “longitudinal movement” (including thespecification and the claims) means movement parallel with centrallongitudinal axis ax1. Therefore longitudinal movement of flange 54 awayfrom coupling point 52 means increasing a distance, measured parallelwith longitudinal axis ax1, between flange 54 and coupling point 52. Anexample of such a configuration is described in more detail with respectto FIG. 3A.

Thus, expansion of tubular portion 32 from its compressed state towardits expanded state (i) increases a circumferential distance between eachof coupling points 52 and its adjacent coupling points (e.g., betweeneach of outer-frame coupling elements 61 and its adjacent outer-framecoupling elements) (e.g., from d8 to d9), and (ii) moves legs 50 in alongitudinally upstream direction with respect to the tubular portion.

Typically, frame assembly 22 is configured such that increasing thediameter of tubular portion 32 also causes longitudinal movement ofupstream support portion 40 toward coupling point 52, e.g., as describedin more detail with respect to FIGS. 3B-C. Typically, frame assembly 22is configured such that increasing the diameter of tubular portion 32also causes longitudinal movement of upstream end 34 of tubular portion32 toward coupling point 52. In the same way, reducing the diameter oftubular portion 32 causes longitudinal movement of upstream end 34 awayfrom coupling point 52.

For some applications, upstream support portion 40 comprises a pluralityof arms 46 that each extends radially outward from tubular portion 32(e.g., from upstream end 34 of the tubular portion). Arms 46 aretypically flexible. For some such applications, arms 46 are coupled totubular portion 32 such that each arm may deflect independently ofadjacent arms during implantation (e.g., due to anatomical topography).

For some applications, upstream support portion 40 comprises a pluralityof barbs 48 that extend out of a downstream surface of the upstreamsupport portion. For example, each arm 46 may comprise one or more ofbarbs 48. Barbs 48 press into tissue upstream of the native valve (e.g.,into the valve annulus), thereby inhibiting downstream movement ofimplant 20 (in addition to inhibition of downstream movement provided bythe geometry of upstream support portion 40).

One or more surfaces of frame assembly 22 are covered with a covering23, which typically comprises a flexible sheet, such as a fabric, e.g.,comprising polyester. Typically, covering 23 covers at least part oftubular portion 32, typically lining an inner surface of the tubularportion, and thereby defining lumen 38.

Further typically, upstream support portion 40 is covered with covering23, e.g., extending between arms 46 to form an annular shape. It ishypothesized that this reduces a likelihood of paravalvular leakage. Forsuch applications, excess covering 23 may be provided between arms 46 ofupstream support portion 40, so as to facilitate their independentmovement. Although FIG. 1A shows covering 23 covering an upstream sideof upstream support portion 40, the covering typically additionally (oralternatively) covers the downstream side of the upstream supportportion. For example, covering 23 may extend over the tips of arms 46and down the outside of the arms, or a separate piece of covering may beprovided on the downstream side of the upstream support portion.Alternatively, each arm 46 may be individually covered in a sleeve ofcovering 23, thereby facilitating independent movement of the arms.

For some applications, at least part of legs 50 (e.g., flanges thereof)is covered with covering 23.

Typically, frame assembly 22 comprises a plurality of legs 50 (e.g., twoor more legs, e.g., 2-16 legs, such as 4-12 legs, such as 6-12 legs),arranged circumferentially around valve frame 30 (e.g., around theoutside of tubular portion 32). Typically, frame assembly 22 comprises aplurality of coupling points 52 at which the legs are coupled to valveframe 30.

As described in more detail hereinbelow (e.g., with reference to FIG.3A), each leg 50 is typically coupled to a coupling point 52 via a strut70. For some applications, each leg 50 is coupled to a plurality of(e.g., two) coupling points 52 via a respective plurality of (e.g., two)struts 70. For some such applications, frame assembly 22 is arrangedsuch that, in the expanded state of the frame assembly, leg 50 isdisposed, circumferentially with respect to tubular portion 32, betweentwo struts, and each of the two struts are disposed, circumferentiallywith respect to the tubular portion, between the leg and a respectivecoupling point 52.

For some applications, a plurality of (e.g., two) legs are coupled toeach coupling point 52 via a respective plurality of (e.g., two) struts70. For some such applications, frame assembly 22 is arranged such that,in the expanded state of the frame assembly, coupling point 52 isdisposed, circumferentially with respect to tubular portion 32, betweentwo struts 70, and each of the two struts are disposed,circumferentially with respect to the tubular portion, between thecoupling point and a respective leg 50.

For some applications, frame assembly 22 comprises an outer frame (e.g.,a leg frame) 60 that circumscribes tubular portion 32, comprises (ordefines) the plurality of legs 50 and the plurality of struts 70, and iscoupled to valve frame 30 at the plurality of coupling points 52, suchthat the plurality of legs are distributed circumferentially around thetubular portion. For such applications, outer frame 60 comprises a ring66 that is defined by a pattern of alternating peaks 64 and troughs 62,and that typically circumscribes tubular portion 32. For example, thering may comprise struts 70, extending between the peaks and troughs.Peaks 64 are longitudinally closer to upstream end 34 of tubular portion32 than to downstream end 36, and troughs 62 are longitudinally closerto the downstream end than to the upstream end. (It is to be noted thatthroughout this patent application, including the specification and theclaims, the term “longitudinally” means with respect to longitudinalaxis ax1. For example, “longitudinally closer” means closer along axisax1 (whether positioned on axis ax1 or lateral to axis ax1), and“longitudinal movement” means a change in position along axis ax1 (whichmay be in additional to movement toward or away from axis ax1).)Therefore, peaks 64 are closer than troughs 62 to upstream end 34, andtroughs 62 are closer than peaks 64 to downstream end 36. Forapplications in which frame 60 comprises ring 66, each leg 50 is coupledto the ring (or defined by frame 60) at a respective trough 62.

In the embodiment shown, the peaks and troughs are defined by ring 66having a generally zig-zag shape. However, the scope of the inventionincludes ring 66 having another shape that defines peaks and troughs,such as a serpentine or sinusoid shape.

For applications in which frame assembly 22 has a plurality of couplingpoints 52, the coupling points (and therefore coupling elements 31 and61) are disposed circumferentially around the frame assembly (e.g.,around axis ax1), typically on a transverse plane that is orthogonal toaxis ax1. This transverse plane is illustrated by the position ofsection A-A in FIG. 2B. Alternatively, coupling points 52 may bedisposed at different longitudinal heights of frame assembly 22, e.g.,such that different flanges 54 are positioned and/or moved differentlyto others. Typically, coupling points 52 (and therefore couplingelements 31 and 61) are disposed longitudinally between upstream end 24and downstream end 26 of frame assembly 22, but not at either of theseends. Further typically, coupling points 52 are disposed longitudinallybetween upstream end 34 and downstream end 36 of tubular portion 32, butnot at either of these ends. For example, the coupling points may bemore than 3 mm (e.g., 4-10 mm) both from end 34 and from end 36. It ishypothesized that this advantageously positions the coupling points at apart of tubular portion 32 that is more rigid than end 34 or end 36.

It is to be noted that leg 50 is typically expandable into its expandedstate (e.g., a released-flange state) such that flange 54 extends awayfrom axis ax1, independently of increasing the diameter of tubularportion 32 (e.g., as shown in FIGS. 2B & 2D). Similarly, upstreamsupport portion 40 is typically expandable into its expanded state(e.g., a released-arm state) such that it (e.g., arms 46 thereof)extends away from axis ax1, independently of increasing the diameter oftubular portion 32 (e.g., as shown in FIGS. 2C & 2D). The state shown inFIG. 2D may be considered to be an intermediate state. Therefore,implant 20 is typically configured such that legs 50 (e.g., flanges 54thereof) and upstream support portion 40 are expandable such that theyboth extend away from axis ax1, while retaining a distance d3therebetween. This distance is subsequently reducible to a distance d4by expanding tubular portion 32 (e.g., shown in FIG. 2E).

For some applications, while tubular portion 32 remains in itscompressed state, flange 54 can extend away from axis ax1 over 40percent (e.g., 40-80 percent, such as 40-70 percent) of the distancethat it extends from the axis subsequent to the expansion of the tubularportion. For example, for applications in which implant 20 comprises aflange on opposing sides of the implant, a span d15 of the flanges whiletubular portion 32 is in its compressed state may be at least 40 percent(e.g., 40-80 percent, such as 40-70 percent) as great as a span d16 ofthe flanges subsequent to the expansion of the tubular portion. For someapplications, span d15 is greater than 15 mm and/or less than 50 mm(e.g., 20-30 mm). For some applications, span d16 is greater than 30 mmand/or less than 60 mm (e.g., 40-50 mm). It is to be noted that flange54 is effectively fully expanded, with respect to other portions of leg50 and/or with respect to tubular portion 32, before and after theexpansion of the tubular portion.

Similarly, for some applications, while tubular portion 32 remains inits compressed state, upstream support portion 40 (e.g., arms 46) canextend away from axis ax1 over 30 percent (e.g., 30-70 percent) of thedistance that it extends from the axis subsequent to the expansion ofthe tubular portion. That is, for some applications, a span d17 of theupstream support portion while tubular portion 32 is in its compressedstate may be at least 30 percent (e.g., 30-70 percent) as great as aspan d18 of the upstream support portion subsequent to the expansion ofthe tubular portion. For some applications, span d17 is greater than 16mm (e.g., greater than 20 mm) and/or less than 50 mm (e.g., 30-40 mm).For some applications, span d18 is greater than 40 mm and/or less than65 mm (e.g., 45-56 mm, such as 45-50 mm). It is to be noted thatupstream support portion 40 is effectively fully expanded, with respectto tubular portion 32, before and after the expansion of the tubularportion.

It is to be noted that when tubular portion 32 is expanded, flanges 54typically translate radially outward from span d15 to span d16 (e.g.,without deflecting). Typically upstream support portion 40 behavessimilarly (e.g., arms 46 translated radially outward from span d17 tospan d18, e.g., without deflecting). That is, an orientation of eachflange 54 and/or each arm 46 with respect to tubular portion 32 and/oraxis ax1 is typically the same in the state shown in FIG. 2D as it is inthe state shown in FIG. 2E. Similarly, for some applications anorientation of each flange 54 with respect to upstream support portion40 (e.g., with respect to one or more arms 46 thereof) is the samebefore and after expansion of tubular portion 32.

For some applications, increasing the diameter of tubular portion 32from d1 to d2 causes greater than 1 mm and/or less than 20 mm (e.g.,1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinal movement of flange54 away from coupling point 52. For some applications, increasing thediameter of tubular portion 32 from d1 to d2 causes greater than 1 mmand/or less than 20 mm (e.g., 1-20 mm, such as 1-10 mm or 5-20 mm) oflongitudinal movement of upstream support portion 40 toward couplingpoint 52. For some applications, distance d3 is 7-30 mm. For someapplications, distance d4 is 0-15 mm (e.g., 2-15 mm). For someapplications, increasing the diameter of tubular portion 32 from d1 tod2 reduces the distance between the upstream support portion and flanges54 by more than 5 mm and/or less than 30 mm, such as 5-30 mm (e.g.,10-30 mm, such as 10-20 mm or 20-30 mm). For some applications, thedifference between d3 and d4 is generally equal to the differencebetween d1 and d2. For some applications, the difference between d3 andd4 is more than 1.2 and/or less than 3 times (e.g., 1.5-2.5 times, suchas about 2 times) greater than the difference between d1 and d2.

For some applications, flanges 54 curve such that a tip of each flangeis disposed at a shallower angle with respect to inner region 42 ofupstream support portion 40, than are portions of leg 50 that are closerto downstream end 26 of frame assembly 22. For some such applications, atip of each flange may be generally parallel with inner region 42. Forsome such applications, while tubular portion 32 is in its expandedstate, a tip portion 55 of each flange 54 that extends from the tip ofthe flange at least 2 mm along the flange, is disposed within 2 mm ofupstream support portion 40. Thus, for some applications, while tubularportion 32 is in its expanded state, for at least 5 percent (e.g., 5-8percent, or at least 8 percent) of span 18 of upstream support portion40, the upstream support portion is disposed within 2 mm of a flange 54.

For some applications, in the absence of any obstruction (such as tissueof the valve or covering 23) between flange 54 and upstream supportportion 40, increasing the diameter of tubular portion 32 from d1 to d2causes the flange and the upstream support portion to move past eachother (e.g., the flange may move between arms 46 of the upstream supportportion), such that the flange is closer to the upstream end of implant20 than is the upstream support portion, e.g., as shown hereinbelow forframe assemblies 122 and 222, mutatis mutandis. (For applications inwhich upstream support portion 40 is covered by covering 23, flanges 54typically don't pass the covering. For example, in the absence of anyobstruction, flanges 54 may pass between arms 46, and press directlyagainst covering 23.) It is hypothesized that for some applications thisconfiguration applies greater force to the valve tissue beingsandwiched, and thereby further facilitates anchoring of the implant.That is, for some applications, distance d3 is smaller than the sum ofdistance d5 and a distance d14 (described with reference to FIG. 3C).For some applications, increasing the diameter of tubular portion 32from d1 to d2 advantageously causes flanges 54 and upstream supportportion 40 to move greater than 3 mm and/or less than 25 mm (e.g.,greater than 5 mm and/or less than 15 mm, e.g., 5-10 mm, such as about 7mm) with respect to each other (e.g., toward each other and then pasteach other).

For some applications, in the expanded state of frame assembly 22,upstream support portion 40 has an inner region (e.g., an inner ring) 42that extends radially outward at a first angle with respect to axis ax1(and typically with respect to tubular portion 32), and an outer region(e.g., an outer ring) 44 that extends, from the inner region, furtherradially outward from the tubular portion at a second angle with respectto the tubular portion, the second angle being smaller than the firstangle. For example, for some applications inner region 42 extendsradially outward at an angle alpha_1 of 60-120 degrees (e.g., 70-110degrees) with respect to axis ax1, and outer region 44 extends radiallyoutward at an angle alpha_2 of 5-70 degrees (e.g., 10-60 degrees) withrespect to axis ax1.

It is to be noted that angles alpha_1 and alpha_2 are measured betweenthe respective region support portion 40, and the portion of axis ax1that extends in an upstream direction from the level of frame assembly22 at which the respective region begins to extend radially outward.

For some applications in which implant 20 is configured to be placed atan atrioventricular valve (e.g., a mitral valve or a tricuspid valve) ofthe subject, region 42 is configured to be placed against the upstreamsurface of the annulus of the atrioventricular valve, and region 44 isconfigured to be placed against the walls of the atrium upstream of thevalve.

For some applications, outer region 44 is more flexible than innerregion 42. For example, and as shown, each arm 46 may have a differentstructure in region 44 than in region 42. It is hypothesized that therelative rigidity of region 42 provides resistance against ventricularmigration of implant 20, while the relative flexibility of region 44facilitates conformation of upstream support portion 40 to the atrialanatomy.

For some applications, two or more of arms 46 are connected by aconnector (not shown), reducing the flexibility, and/or the independenceof movement of the connected arms relative to each other. For someapplications, arms 46 are connected in particular sectors of upstreamsupport portion 40, thereby making these sectors more rigid than sectorsin which the arms are not connected. For example, a relatively rigidsector may be provided to be placed against the posterior portion of themitral annulus, and a relatively flexible sector may be provided to beplaced against the anterior side of the mitral annulus, so as to reduceforces applied by upstream support portion 40 on the aortic sinus.

For some applications, and as shown, coupling points 52 are disposedcloser to downstream end 26 of frame assembly 22 than are flanges 54, oris upstream support portion 40.

As described in more detail with respect to FIGS. 4A-F, the movement offlange 54 away from coupling point 52 (and the typical movement ofupstream support portion 40 toward the coupling point) facilitates thesandwiching of tissue of the native valve (e.g., leaflet and/or annulustissue) between the flange and the upstream support portion, therebysecuring implant 20 at the native valve.

Typically, in the compressed state of tubular portion 32, a downstreamend of each leg 50 is longitudinally closer than valve-frame couplingelements 31 to downstream end 36, and flange 54 of each leg is disposedlongitudinally closer than the valve-frame coupling elements to upstreamend 34. Typically, this is also the case in the expanded state oftubular portion 32.

FIGS. 3A-C show structural changes in frame assembly 22 duringtransitioning of the assembly between its compressed and expandedstates, in accordance with some applications of the invention. FIGS.3A-C each show a portion of the frame assembly, the structural changesthereof being representative of the structural changes that occur inother portions of the frame assembly. FIG. 3A shows a leg 50 and struts70 (e.g., a portion of outer frame 60), and illustrates the structuralchanges that occur around outer frame 60. FIG. 3B shows a portion ofvalve frame 30, and illustrates the structural changes that occur aroundthe valve frame. FIG. 3C shows valve frame 30 as a whole. In each ofFIGS. 3A-C, state (A) illustrates the structure while frame assembly 22(and in particular tubular portion 32) is in its compressed state, andstate (B) illustrates the structure while the frame assembly (and inparticular tubular portion 32) is in its expanded state.

FIG. 3A shows structural changes in the coupling of legs 50 to couplingpoint 52 (e.g., structural changes of outer frame 60) during thetransitioning of frame assembly 22 (and in particular tubular portion32) between its compressed and expanded states. Each leg 50 is coupledto valve frame 30 via at least one strut 70, which connects the leg tocoupling point 52. Typically, each leg 50 is coupled to valve frame 30via a plurality of struts 70. A first end 72 of each strut 70 is coupledto leg 50, and a second end 74 of each strut is coupled to a couplingpoint 52. As described hereinabove, for applications in which frame 60comprises ring 66, each leg 50 is coupled to the ring at a respectivetrough 62. Ring 66 may comprise struts 70, extending between the peaksand troughs, with each first end 72 at (or close to) a trough 62, andeach second end 74 at (or close to) a peak 64.

In the compressed state of frame assembly 22 (and in particular oftubular portion 32), each strut 70 is disposed at a first angle in whichfirst end 72 is disposed closer than second end 74 to the downstream endof the frame assembly. Expansion of frame assembly 22 (and in particularof tubular portion 32) toward its expanded state causes strut 70 todeflect to a second angle. This deflection moves first end 72 away fromthe downstream end of frame assembly 22. That is, in the expanded stateof frame assembly 22, first end 72 is further from the downstream end ofthe frame assembly than it is when the frame assembly is in itscompressed state. This movement is shown as a distance d5 between theposition of end 72 in state (A) and its position in state (B). Thismovement causes the above-described movement of flanges 54 away fromcoupling points 52. As shown, flanges 54 typically move the samedistance d5 in response to expansion of frame assembly 22.

For applications in which outer frame 60 comprises ring 66, the patternof alternating peaks and troughs may be described as having an amplitudelongitudinally between the peaks and troughs, i.e., measured parallelwith central longitudinal axis ax1 of frame assembly 22, and thetransition between the compressed and expanded states may be describedas follows: In the compressed state of frame assembly 22 (and inparticular of tubular portion 32), the pattern of ring 66 has anamplitude d20. In the expanded state frame assembly 22 (and inparticular of tubular portion 32), the pattern of ring 66 has anamplitude d21 that is lower than amplitude d20. Because (i) it is atpeaks 64 that ring 66 is coupled to valve frame 30 at coupling points52, and (ii) it is at troughs 62 that ring 66 is coupled to legs 50,this reduction in the amplitude of the pattern of ring 66 moves legs 50(e.g., flanges 54 thereof) longitudinally further from the downstreamend of the frame assembly. The magnitude of this longitudinal movement(e.g., the difference between magnitudes d20 and d21) is equal to d5.

Typically, distance d5 is the same distance as the distance that flange54 moves away from coupling point 52 during expansion of the frameassembly. That is, a distance between flange 54 and the portion of leg50 that is coupled to strut 70, typically remains constant duringexpansion of the frame assembly. For some applications, the longitudinalmovement of flange 54 away from coupling point 52 is a translationalmovement (e.g., a movement that does not include rotation or deflectionof the flange).

For some applications, a distance d6, measured parallel to axis ax1 offrame assembly 22, between coupling point 52 and first end 72 of strut70 while assembly 22 is in its compressed state, is 3-15 mm. For someapplications, a distance d7, measured parallel to axis ax1, betweencoupling point 52 and first end 72 of strut 70 while assembly 22 is inits expanded state, is 1-5 mm (e.g., 1-4 mm).

For some applications, amplitude d20 is 2-10 mm (e.g., 4-7 mm). For someapplications, amplitude d21 is 4-9 mm (e.g., 5-7 mm).

For some applications, and as shown, in the expanded state, first end 72of strut 70 is disposed closer to the downstream end of frame assembly22 than is coupling point 52. For some applications, in the expandedstate, first end 72 of strut 70 is disposed further from the downstreamend of frame assembly 22 than is coupling point 52.

For applications in which frame assembly 22 comprises a plurality oflegs 50 and a plurality of coupling points 52 (e.g., for applications inwhich the frame assembly comprises outer frame 60) expansion of theframe assembly increases a circumferential distance between adjacentcoupling points 52, and an increase in a circumferential distancebetween adjacent legs 50. FIG. 3A shows such an increase in thecircumferential distance between adjacent coupling points 52, from acircumferential distance d8 in the compressed state to a circumferentialdistance d9 in the expanded state. For some applications, distance d8 is1-6 mm. For some applications, distance d9 is 3-15 mm

For some applications, in addition to being coupled via ring 66 (e.g.,struts 70 thereof) legs 50 are also connected to each other viaconnectors 78. Connectors 78 allow the described movement of legs 50during expansion of frame assembly 22, but typically stabilize legs 50relative to each other while the frame assembly is in its expandedstate. For example, connectors 78 may bend and/or deflect duringexpansion of the frame assembly.

FIGS. 3B-C show structural changes in valve frame 30 during thetransitioning of frame assembly 22 between its compressed and expandedstates. Tubular portion 32 of valve frame 30 is defined by a pluralityof cells 80, which are defined by the repeating pattern of the valveframe. When frame assembly 22 is expanded from its compressed statetoward its expanded state, cells 80 (i) widen from a width d10 to awidth d11 (measured orthogonal to axis ax1 of the frame assembly), and(ii) shorten from a height d12 to a height d13 (measured parallel toaxis ax1 of the frame assembly). This shortening reduces the overallheight (i.e., a longitudinal length between upstream end 34 anddownstream end 36) of tubular portion 32 from a height d22 to a heightd23, and thereby causes the above-described longitudinal movement ofupstream support portion 40 toward coupling points 52 by a distance d14(shown in FIG. 3C). For some applications, and as shown, coupling points52 are disposed at the widest part of each cell.

Due to the configurations described herein, the distance by whichflanges 54 move with respect to (e.g., toward, or toward-and-beyond)upstream support portion 40 (e.g., arms 46 thereof), is typicallygreater than the reduction in the overall height of tubular portion 32(e.g., more than 20 percent greater, such as more than 30 percentgreater, such as more than 40 percent greater). That is, implant 20comprises:

-   -   a valve frame (30) that comprises a tubular portion (32) that        circumscribes a longitudinal axis (ax1) of the valve frame so as        to define a lumen (38) along the axis, the tubular portion        having an upstream end (34), a downstream end (36), a        longitudinal length therebetween, and a diameter (e.g., d1 or        d2) transverse to the longitudinal axis;    -   a valve member (58), coupled to the tubular portion, disposed        within the lumen, and arranged to provide unidirectional        upstream-to-downstream flow of blood through the lumen;    -   an upstream support portion (40), coupled to the tubular        portion; and    -   an outer frame (60), coupled to the tubular portion, and        comprising a tissue-engaging flange (54),

wherein:

-   -   the implant has a first state (e.g., as shown in FIG. 2D and        FIG. 4D) and a second state (e.g., as shown in FIG. 2E and FIG.        4E),    -   in both the first state and the second state, (i) the upstream        support portion extends radially outward from the tubular        portion, and (ii) the tissue-engaging flange extends radially        outward from the tubular portion, and    -   the tubular portion, the upstream support portion, and the outer        frame are arranged such that transitioning of the implant from        the first state toward the second state:        -   increases the diameter of the tubular portion by a            diameter-increase amount (e.g., the difference between d1            and d2),        -   decreases the length of the tubular portion by a            length-decrease amount (e.g., the difference between d22 and            d23), and        -   moves the flange a longitudinal distance with respect to            (e.g., toward or toward-and-beyond) the upstream support            portion (e.g., the difference between d3 and d4), this            distance being greater than the length-decrease amount.

As shown in the figures, valve frame 30 is typically coupled to outerframe 60 by coupling between (i) a valve-frame coupling element 31defined by valve frame 30, and (ii) an outer-frame coupling element 61defined by outer frame 60 (e.g., an outer-frame coupling element iscoupled to end 74 of each strut). Typically, elements 31 and 61 arefixed with respect to each other. Each coupling point 52 is therebytypically defined as the point at which a valve-frame coupling elementand a corresponding outer-frame coupling element 61 are coupled (e.g.,are fixed with respect to each other). For some applications, and asshown, elements 31 and 61 are eyelets configured to be coupled togetherby a connector, such as a pin or suture. For some applications, elements31 and 61 are soldered or welded together.

Typically, and as shown, valve-frame coupling elements 31 are defined bytubular portion 32, and are disposed circumferentially around centrallongitudinal axis ax1. Outer-frame coupling elements 61 are coupled toring 66 (or defined by frame 60, such as by ring 66) at respective peaks64.

As shown (e.g., in FIGS. 2A-E), valve frame 30 (e.g., tubular portion 32thereof) and outer frame 60 (e.g., ring 66 thereof) are arranged in aclose-fitting coaxial arrangement, in both the expanded and compressedstates of frame assembly 22. Ignoring spaces due to the cellularstructure of the frames, a radial gap d19 between valve frame 30 (e.g.,tubular portion 32 thereof) and outer frame 60 (e.g., ring 66 thereof)is typically less than 2 mm (e.g., less than 1 mm), in both thecompressed and expanded states, and during the transition therebetween.This is facilitated by the coupling between frames 30 and 60, and thebehavior, described hereinabove, of frame 60 in response to changes inthe diameter of tubular portion 32 (e.g., rather than solely due todelivery techniques and/or tools). For some applications, more than 50percent (e.g., more than 60 percent) of ring 66 is disposed within 2 mmof tubular portion 32 in both the compressed and expanded states, andduring the transition therebetween. For some applications, more than 50percent (e.g., more than 60 percent) of outer frame 60, except forflanges 54, is disposed within 2 mm of tubular portion 32 in both thecompressed and expanded states, and during the transition therebetween.

The structural changes to frame assembly 22 (e.g., to outer frame 60thereof) are described hereinabove as they occur during (e.g., as aresult of) expansion of the frame assembly (in particular tubularportion 32 thereof). This is the natural way to describe these changesbecause, as described hereinbelow with respect to FIGS. 4A-6, assembly22 is in its compressed state during percutaneous delivery to theimplant site, and is subsequently expanded. However, the nature ofimplant 20 may be further understood by describing structural changesthat occur during compression of the frame assembly (e.g., a transitionfrom the expanded state in FIG. 2E to the intermediate state in FIG.2D), in particular tubular portion 32 thereof (including if tubularportion 32 were compressed by application of compressive force to thetubular portion, and not to frame 60 except via the tubular portionpulling frame 60 radially inward). Such descriptions may also berelevant because implant 20 is typically compressed (i.e., “crimped”)soon before its percutaneous delivery, and therefore these changes mayoccur while implant 20 is in the care of the operating physician.

For some applications, the fixation of peaks 64 to respective sites oftubular portion 32 is such that compression of the tubular portion fromits expanded state toward its compressed state such that the respectivesites of the tubular portion pull the peaks radially inward viaradially-inward tension on coupling points 52: (i) reduces acircumferential distance between each of the coupling points and itsadjacent coupling points (e.g., from d9 to d8), and (ii) increases theamplitude of the pattern of ring 66 (e.g., from d21 to d20).

For some applications, the fixation of outer-frame coupling elements 61to valve-frame coupling elements 31 is such that compression of tubularportion 32 from its expanded state toward its compressed state such thatthe valve-frame coupling elements pull the outer-frame coupling elementsradially inward: (i) reduces a circumferential distance between each ofthe outer-frame coupling elements and its adjacent outer-frame couplingelements (e.g., from d9 to d8), and (ii) increases the amplitude of thepattern of ring 66 (e.g., from d21 to d20).

For some applications, the fixation of peaks 64 to the respective sitesof tubular portion 32 is such that compression of the tubular portionfrom its expanded state toward its compressed state (i) pulls the peaksradially inward via radially-inward pulling of the respective sites ofthe tubular portion on the peaks, (ii) reduces a circumferentialdistance between each of coupling points 52 and its adjacent couplingpoints (e.g., from d9 to d8), and (iii) increases the amplitude of thepattern of ring 66 (e.g., from d21 to d20), without increasing radialgap d19 between valve frame 30 (e.g., tubular portion 32 thereof) andthe ring by more than 1.5 mm.

For some applications, the fixation of outer-frame coupling elements 61with respect to valve-frame coupling elements 31 is such thatcompression of tubular portion 32 from its expanded state toward itscompressed state (i) pulls outer-frame coupling elements 61 radiallyinward via radially-inward pulling of valve-frame coupling elements 31on outer-frame coupling elements 61, (ii) reduces a circumferentialdistance between each of the outer-frame coupling elements and itsadjacent outer-frame coupling elements (e.g., from d9 to d8), and (iii)increases the amplitude of the pattern of ring 66 (e.g., from d21 tod20), without increasing radial gap d19 between valve frame 30 (e.g.,tubular portion 32 thereof) and the ring by more than 1.5 mm

Reference is made to FIGS. 4A-F, which are schematic illustrations ofimplantation of implant 20 at a native valve 10 of a heart 4 of asubject, in accordance with some applications of the invention. Valve 10is shown as a mitral valve of the subject, disposed between a leftatrium 6 and a left ventricle 8 of the subject. However implant 20 maybe implanted at another heart valve of the subject, mutatis mutandis.Similarly, although FIGS. 4A-F show implant 20 being deliveredtransseptally via a sheath 88, the implant may alternatively bedelivered by any other suitable route, such as transatrially, ortransapically.

Implant 20 is delivered, in its compressed state, to native valve 10using a delivery tool 89 that is operable from outside the subject (FIG.4A). Typically, implant 20 is delivered within a delivery capsule 90 oftool 89, which retains the implant in its compressed state. Atransseptal approach, such as a transfemoral approach, is shown.Typically, implant 20 is positioned such that at least flanges 54 aredisposed downstream of the native valve (i.e., within ventricle 8). Atthis stage, frame assembly 22 of implant 20 is as shown in FIG. 2A.

Subsequently, flanges 54 are allowed to protrude radially outward, asdescribed hereinabove, e.g., by releasing them from capsule 90 (FIG.4B). For example, and as shown, capsule 90 may comprise a distalcapsule-portion 92 and a proximal capsule-portion 94, and the distalcapsule-portion may be moved distally with respect to implant 20, so asto expose flanges 54. At this stage, frame assembly 22 of implant 20 isas shown in FIG. 2B.

Subsequently, implant 20 is moved upstream, such that upstream supportportion 40, in its compressed state, is disposed upstream of leaflets 12(i.e., within atrium 6). For some applications, the upstream movement ofimplant 20 causes flanges 54 to engage leaflets 12. However, because ofthe relatively large distance d3 provided by implant 20 (describedhereinabove), for some applications it is not necessary to move theimplant so far upstream that flanges 54 tightly engage leaflets 12and/or pull the leaflets upstream of the valve annulus. Upstream supportportion 40 is then allowed to expand such that it protrudes radiallyoutward, as described hereinabove, e.g., by releasing it from capsule 90(FIG. 4D). For example, and as shown, proximal capsule-portion 94 may bemoved proximally with respect to implant 20, so as to expose upstreamsupport portion 40. At this stage, frame assembly 22 of implant 20 is asshown in FIG. 2D, in which: (i) distance d3 exists between upstreamsupport portion 40 and flanges 54, (ii) the flanges have span d15, (iii)the upstream support portion has span d17, and (iv) tubular portion 32has diameter d1.

Typically, expansion of frame assembly 22 is inhibited by distalcapsule-portion 92 (e.g., by inhibiting expansion of tubular portion32), and/or by another portion of delivery tool 89 (e.g., a portion ofthe delivery tool that is disposed within lumen 38).

Subsequently, implant 20 is allowed to expand toward its expanded state,such that tubular portion 32 widens to diameter d2, and the distancebetween upstream support portion 40 and flanges 54 reduces to distanced4 (FIG. 4E). This sandwiches tissue of valve 10 (typically includingannular tissue and/or leaflets 12) between upstream support portion 40and flanges 54, thereby securing implant 20 at the valve. FIG. 4F showsdelivery capsule 90 having been removed from the body of the subject,leaving implant 20 in place at valve 10.

As described hereinabove, implant 20 is configured such that whentubular portion 32 is expanded, flanges 54 and upstream support portion40 move a relatively large distance toward each other. This enablesdistance d3 to be relatively large, while distance d4 is sufficientlysmall to provide effective anchoring. As also described hereinabove,implant 20 is configured such that flanges 54 and upstream supportportion 40 can extend radially outward a relatively large distance whiletubular portion 32 remains compressed. It is hypothesized that for someapplications, these configurations (independently and/or together)facilitate effective anchoring of implant 20, by facilitating placementof a relatively large proportion of valve tissue (e.g., leaflets 12)between the flanges and the upstream support portion prior to expandingtubular portion 32 and sandwiching the valve tissue.

It is further hypothesized that the relatively great radially-outwardextension of flanges 54 and upstream support portion 40 prior toexpansion of tubular portion 32, further facilitates theanchoring/sandwiching step by reducing radially-outward pushing of thevalve tissue (e.g., leaflets 12) during the expansion of the tubularportion, and thereby increasing the amount of valve tissue that issandwiched.

It is yet further hypothesized that this configuration of implant 20facilitates identifying correct positioning of the implant (i.e., withupstream support portion 40 upstream of leaflets 12 and flanges 54downstream of the leaflets) prior to expanding tubular portion 32 andsandwiching the valve tissue.

As shown in FIG. 1A, for some applications, in the expanded state offrame assembly 22, implant 20 defines a toroidal space 49 betweenflanges 54 and upstream support portion 40 (e.g., a space that is widerthan distance d4). For example, space 49 may have a generally triangularcross-section. It is hypothesized that for some such applications, inaddition to sandwiching tissue of the native valve between upstreamsupport portion 40 and flanges 54 (e.g., the tips of the flanges), space49 advantageously promotes tissue growth therewithin (e.g., betweenleaflet tissue and covering 23), which over time further secures implant20 within the native valve.

Reference is now made to FIG. 5, which is a schematic illustration of astep in the implantation of implant 20, in accordance with someapplications of the invention. Whereas FIGS. 4A-F show an implantationtechnique in which flanges 54 are expanded prior to upstream supportportion 40, for some applications the upstream support portion isexpanded prior to the flanges. FIG. 5 shows a step in such anapplication.

Reference is again made to FIGS. 2A-5. As noted hereinabove, implant 20may be implanted by causing flanges 54 to radially protrude beforecausing upstream support portion 40 to radially protrude, or may beimplanted by causing the upstream support portion to protrude beforecausing the flanges to protrude. For some applications, implant 20 isthereby configured to be deliverable in a downstream direction (e.g.,transseptally, as shown, or transapically) or in an upstream direction(e.g., transapically or via the aortic valve). Thus, for someapplications, an operating physician may decide which delivery route ispreferable for a given application (e.g., for a given subject, and/orbased on available equipment and/or expertise), and implant 20 isresponsively prepared for the chosen delivery route (e.g., by loadingthe implant into an appropriate delivery tool).

It is to be noted that for some applications, downstream delivery ofimplant 20 may be performed by expanding flanges 54 first (e.g., asshown in FIGS. 4A-F) or by expanding upstream support portion 40 first(e.g., as shown in FIG. 5). Similarly, for some applications upstreamdelivery of implant 20 may be performed by upstream support portion 40first, or by expanding flanges 54 first.

Reference is now made to FIG. 6, which is a schematic illustration ofimplant 20, in the state and position shown in FIG. 4D, in accordancewith some applications of the invention. For some applications, whileimplant 20 is in the state and position shown in FIG. 4D, leaflets 12 ofvalve 10 are able to move, at least in part in response to beating ofthe heart. Frame (A) shows leaflets 12 during ventricular systole, andframe (B) shows the leaflets during ventricular diastole. For some suchapplications, blood is thereby able to flow from atrium 6 to ventricle8, between leaflets 12 and implant 20. It is hypothesized that thisadvantageously facilitates a more relaxed implantation procedure, e.g.,facilitating retaining of implant 20 in this state and position for aduration of greater than 8 minutes. During this time, imaging techniquesmay be used to verify the position of implant 20, and/or positioning ofleaflets 12 between upstream support portion 40 and flanges 54.

Reference is made to FIGS. 7A-B and 8A-B, which are schematicillustrations of frame assemblies 122 and 222 of respective implants, inaccordance with some applications of the invention. Except where notedotherwise, frame assemblies 122 and 222 are typically identical to frameassembly 22, mutatis mutandis. Elements of frame assemblies 122 and 222share the name of corresponding elements of frame assembly 22.Additionally, except where noted otherwise, the implants to which frameassemblies 122 and 222 belong are similar to implant 20, mutatismutandis.

Frame assembly 122 comprises (i) a valve frame 130 that comprises atubular portion 132 and an upstream support portion 140 that typicallycomprises a plurality of arms 146, and (ii) an outer frame (e.g., a legframe) 160 that circumscribes the valve frame, and comprises a pluralityof legs 150 that each comprise a tissue-engaging flange 154. Typically,outer frame 160 comprises a ring 166 to which legs 150 are coupled. Ring166 is defined by a pattern of alternating peaks and troughs, the peaksbeing fixed to frame 130 at respective coupling points 152, e.g., asdescribed hereinabove for frame assembly 22, mutatis mutandis.

Frame assembly 222 comprises (i) a valve frame 230 that comprises atubular portion 232 and an upstream support portion 240 that typicallycomprises a plurality of arms 246, and (ii) an outer frame (e.g., a legframe) 260 that circumscribes the valve frame, and comprises a pluralityof legs 250 that each comprise a tissue-engaging flange 254. Typically,outer frame 260 comprises a ring 266 to which legs 250 are coupled. Ring266 is defined by a pattern of alternating peaks and troughs, the peaksbeing fixed to frame 230 at respective coupling points 252, e.g., asdescribed hereinabove for frame assembly 22, mutatis mutandis.

Whereas arms 46 of frame assembly 22 are shown as extending fromupstream end 34 of tubular portion 32, arms 146 and 246 of frameassemblies 122 and 222, respectively, extend from sites furtherdownstream. (This difference may also be made to frame assembly 22,mutatis mutandis.) Tubular portions 32, 132 and 232 are each defined bya repeating pattern of cells that extends around the centrallongitudinal axis. Typically, and as shown, tubular portions 32, 132 and232 are each defined by two stacked, tessellating rows of cells. In theexpanded state of each tubular portion, these cells are typicallynarrower at their upstream and downstream extremities than midwaybetween these extremities. For example, and as shown, the cells may beroughly diamond or astroid in shape. In frame assembly 22, each arm 46is attached to and extends from a site 35 that is at the upstreamextremity of cells of the upstream row. In contrast, in frame assemblies122 and 222, each arm 146 or 246 is attached to and extends from a site135 (assembly 122) or 235 (assembly 222) that is at the connectionbetween two adjacent cells of the upstream row (alternatively describedas being at the upstream extremity of cells of the downstream row).

It is hypothesized by the inventors that this lower position of thearms, while maintaining the length of the lumen of the tubular portion,advantageously reduces the distance that the tubular portion (i.e., thedownstream end thereof) extends into the ventricle of the subject, andthereby reduces a likelihood of inhibiting blood flow out of theventricle through the left ventricular outflow tract. It is furtherhypothesized that this position of the arms reduces radial compressionof the tubular portion by movement of the heart, due to greater rigidityof the tubular portion at sites 135 and 235 (which is supported by twoadjacent cells) than at site 35 (which is supported by only one cell).

As shown, in the expanded state of frame assemblies 22, 122 and 222, thelegs (50, 150 and 250, respectively) are circumferentially staggeredwith the arms of the upstream support portion (46, 146 and 246,respectively). This allows the legs to move in an upstream directionbetween the arms during expansion of the tubular portion (32, 132 and232, respectively), facilitating application of greater sandwichingforce on tissue of the native valve. The lower position of the arms ofassemblies 122 and 222 includes circumferentially shifting the positionof the arms by the width of half a cell. In order to maintain thecircumferential staggering of the arms and legs, rings 166 and 266 (andthereby legs 150 and 250) are circumferentially shifted correspondingly.As a result, whereas the peaks of ring 66 generally align withconnections between adjacent cells of the downstream row of cells oftubular portion 32 (and are fixed to these sites), the peaks of rings166 and 266 are generally aligned midway between these sites (i.e., atspaces of the cellular structure of the tubular portion). Appendages 168(for assembly 122) or 268 (for assembly 222) facilitate fixing of thepeak with respect to the tubular structure.

For assembly 122, appendages 168 are defined by valve frame 130 (e.g.,by tubular portion 132 thereof) and extend (in a downstream direction)to the peaks of ring 166, to which they are fixed. For example, eachappendage 168 may define a valve-frame coupling element 131 that isfixed to a respective outer-frame coupling element 161 defined by outerframe 260. Typically, appendages 168 extend from sites 135. Typically,appendages 168 are integral with tubular portion 132 and/or in-planewith the tubular portion (e.g., are part of its tubular shape).

For assembly 222, appendages 268 are defined by outer frame 260, andextend (e.g., in an upstream direction) from the peaks of ring 266.Typically, appendages 268 extend to sites 235, to which they are fixed.For example, each appendage 268 may define an outer-frame couplingelement 261 that is fixed to a respective valve-frame coupling element231 defined by valve frame 230 (e.g., by tubular portion 232 thereof).Typically, appendages 268 are integral with outer frame 260 and/orin-plane with adjacent portions of outer frame 260, such as ring 266.

Therefore, frame assembly 122 defines a hub at site 135, and frameassembly 222 defines a hub at site 235. For some applications, apparatustherefore comprises:

-   -   a plurality of prosthetic valve leaflets; and    -   a frame assembly, comprising:        -   a tubular portion (132 or 232) defined by a repeating            pattern of cells, the tubular portion extending            circumferentially around longitudinal axis ax1 so as to            define a longitudinal lumen, the prosthetic valve leaflets            coupled to the inner frame and disposed within the lumen;        -   an outer frame (160 or 260), comprising a plurality of legs            (150 or 250), distributed circumferentially around the            tubular portion, each leg having a tissue-engaging flange            (154 or 254);        -   an upstream support portion (140 or 240) that comprises a            plurality of arms (146 or 246) that extend radially outward            from the tubular portion; and a plurality of appendages (168            or 268), each having a first end that defines a coupling            element (161 or 261) via which the tubular portion is            coupled to the outer frame, and a second end;    -   wherein the frame assembly defines a plurality of hubs (135 or        235), distributed circumferentially around the longitudinal axis        on a plane that is transverse to longitudinal axis ax1, each hub        defined by convergence and connection of, (i) two adjacent cells        of the tubular portion, (ii) an arm of the plurality of arms,        and (iii) an appendage of the plurality of appendages.

Reference is made to FIGS. 9A-C, which are schematic illustrations of animplant 320 comprising a frame assembly 322, in accordance with someapplications of the invention. Except where noted otherwise, frameassembly 322 is identical to frame assembly 122, and implant 300 isidentical to the implant to which frame assembly 122 belongs, mutatismutandis. FIG. 9A is a side-view of implant 320, and FIG. 9B is anisometric bottom-view of the implant.

Frame assembly 122 comprises (i) a valve frame 330 that comprises atubular portion 332 and an upstream support portion 340 that typicallycomprises a plurality of arms 346, and (ii) an outer frame (e.g., a legframe) 360 that circumscribes the valve frame, and comprises a pluralityof legs 350 that each comprise a tissue-engaging flange 354. Typically,outer frame 360 comprises a ring 366 to which legs 350 are coupled. Ring366 is defined by a pattern of alternating peaks and troughs, the peaksbeing fixed to frame 330 at respective coupling points 352, e.g., asdescribed hereinabove for frame assembly 22 and/or frame assembly 122,mutatis mutandis.

Frame assembly 322 comprises an annular upstream support portion 340that has an inner portion 342 that extends radially outward from theupstream portion (e.g., the upstream end) of tubular portion 332.Upstream support portion 340 further comprises one or more fabricpockets 344 disposed circumferentially around inner portion 342, eachpocket of the one or more pockets having an opening that faces adownstream direction (i.e., generally toward the downstream end ofimplant 320). In the figures, upstream support portion 340 has a singletoroidal pocket 344 that extends circumferentially around inner portion342.

Typically, a covering 323 (e.g., similar to covering 23, describedhereinabove, mutatis mutandis) is disposed over arms 346, therebyforming pocket 344. Further typically, arms 346 are shaped to formpocket 344 from covering 323. For example, and as shown, arms 346 maycurve to form a hook-shape.

For some applications, portion 340 has a plurality of separate pockets344, e.g., separated at arms 346. For some such applications, covering323 is loosely-fitted (e.g., baggy) between radially-outward parts ofarms 346, e.g., compared to inner portion 342, in which the covering ismore closely-fitted between radially-inward parts of the arms.

FIG. 9C shows implant 320 implanted at native valve 10. Pocket 344 istypically shaped and arranged to billow in response to perivalvular flow302 of blood in an upstream direction. If ventricular systole forcesblood in ventricle 8 between implant 320 and native valve 10, that bloodinflates pocket 344 and presses it (e.g., covering 323 and/or theradially-outward part of arm 346) against tissue of atrium 6 (e.g.,against the atrial wall), thereby increasing sealing responsively. It ishypothesized by the inventors that the shape and orientation of pocket344 (e.g., the hook-shape of arms 346) facilitates this pressingradially-outward in response to the pocket's receipt of upstream-flowingblood.

Pocket(s) 344 may be used in combination with any of the implantsdescribed herein, mutatis mutandis.

Reference is again made to FIGS. 1A-9C. It is to be noted that unlessspecifically stated otherwise, the term “radially outward” (e.g., usedto describe upstream support portion 40 and flanges 54) means portionsof the element are disposed progressively further outward from a centralpoint (such as longitudinal axis ax1 or tubular portion 32), but doesnot necessarily mean disposed at 90 degrees with respect to longitudinalaxis ax1. For example, flanges 54 may extend radially outward at 90degrees with respect to longitudinal axis ax1, but may alternativelyextend radially outward at a shallower angle with respect to thelongitudinal axis.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. Apparatus for use with a native valve thatis disposed between an atrium and a ventricle of a heart of a subject,the apparatus comprising: a valve frame, shaped to define a tubularportion that circumscribes a longitudinal axis of the valve frame so asto define a lumen along the axis; a plurality of prosthetic leaflets,coupled to the frame, disposed within the lumen, and arranged to provideunidirectional flow of blood from an upstream end of the lumen to adownstream end of the lumen; and an outer frame, shaped to define: afirst ring, circumscribing the tubular portion, and defined by a patternof alternating peaks and troughs, the peaks being longitudinally closerto the upstream end than to the downstream end, the troughs beinglongitudinally closer to the downstream end than to the upstream end, asecond ring, circumscribing the tubular portion, and defined by apattern of alternating peaks and troughs, and a plurality of legs, eachof the legs coupled to the first ring and to the second ring, anddefining a tissue-engaging flange configured to engage tissue of theventricle, wherein: the tubular portion defines: a plurality of upstreamcells arranged in an upstream row that circumscribes the axis, each ofthe upstream cells being connected to each of two adjacent upstreamcells at a respective upstream-cell-connection site; and a plurality ofdownstream cells arranged in a downstream row that circumscribes theaxis and is tessellated with the upstream row, each of the downstreamcells being connected to each of two adjacent downstream cells at arespective downstream-cell-connection site, and the valve frame isfurther shaped to define a plurality of atrial arms, each of the atrialarms: attached to, and extending from, a respectiveupstream-cell-connection site, and configured to be placed against anupstream surface of the native valve.
 2. The apparatus according toclaim 1, wherein the downstream row is tessellated with the upstream rowsuch that each of the upstream-cell-connection sites is an upstreamextremity of a respective downstream cell.
 3. The apparatus according toclaim 1, wherein a respective atrial arm of the plurality of atrial armsextends from every one of the upstream-cell-connection sites.
 4. Theapparatus according to claim 1, wherein each of the upstream cells isroughly diamond-shaped.
 5. The apparatus according to claim 4, whereineach of the downstream cells is roughly diamond-shaped.
 6. The apparatusaccording to claim 1, wherein each of the legs is coupled to the firstring at a respective one of the troughs of the first ring.
 7. Theapparatus according to claim 6, wherein each of the legs is coupled tothe second ring at a respective one of the troughs of the second ring.8. The apparatus according to claim 1, wherein the second ring islongitudinally closer than the first ring to the upstream end, andwherein the outer frame is fixed to the tubular portion at a pluralityof coupling points, the plurality of coupling points beingcircumferentially arranged around the axis on a transverse plane that is(i) orthogonal to the axis, and (ii) longitudinally between the upstreamend and the downstream end, but not at the upstream end or thedownstream end.
 9. The apparatus according to claim 1, wherein thesecond ring is longitudinally closer than the first ring to the upstreamend, and wherein the outer frame is fixed to the tubular portion at aplurality of coupling points, the plurality of coupling points beingcircumferentially arranged around the axis on a transverse plane that is(i) orthogonal to the axis, and (ii) longitudinally between the troughsof the second ring and the troughs of the first ring.
 10. The apparatusaccording to claim 9, wherein the transverse plane is longitudinallybetween the troughs of the second ring and the peaks of the first ring.11. The apparatus according to claim 1, wherein the pattern of the firstring and the pattern of the second ring are in phase, such that thepeaks of the first ring are circumferentially aligned with the peaks ofthe second ring, and the troughs of the first ring are circumferentiallyaligned with the troughs of the second ring.
 12. The apparatus accordingto claim 1, wherein: the second ring is longitudinally closer than thefirst ring to the upstream end, each of the legs has a first portionthat extends between the first ring and the second ring, and the flangeof each of the legs is longitudinally closer than the second ring to theupstream end.
 13. The apparatus according to claim 12, wherein the firstring is coupled to each of the legs at a downstream end of the leg. 14.The apparatus according to claim 12, wherein each of the arms extendsradially outward, upstream of a respective peak of the second ring. 15.The apparatus according to claim 1, wherein each of the peaks of thefirst ring is circumferentially aligned with a respective one of thearms.
 16. The apparatus according to claim 1, wherein each of the peaksof the first ring is circumferentially aligned with a respective one ofthe upstream-cell-connection sites.